The FDA established a public docket to get stakeholder comment on the development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.
Noting the FDA has proposed at least 22 research studies concerning prescription drug advertising and promotion in the past five years, the Pharmaceutical Research and Manufacturers of America (PhRMA) said it is concerned the agency “has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health.”
A survey of 1,564 U.S. adults in April, which was conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), found while viewership of DTC ads is widespread, 61 percent of respondents had never talked to their physician about a medicine as a result of seeing or hearing an ad.
An analysis of payments made to physicians by opioid manufacturers between August 2013 and December 2015 found more than 68,177 U.S. physicians (about 8 percent of all U.S. physicians) received 375,266 non-research opioid-related payments that totaled $46,158,388.
Two recent federal appellate court decisions illustrated how judges evaluate the regulatory burden in commercial speech decisions using the Central Hudson First Amendment test, a July 28 Washington Legal Foundation Legal Opinion Letter said.